Device, system, and method to secure an article to a tissue

ABSTRACT

A device for securing an article to a tissue may include a body, transitionable from a deployment state to a securing state, having a first portion, a second portion, and a medial portion therebetween. The first portion and the second portion may each have an end configured to pierce the tissue. The device in the deployment state may have a linearly extended or a U-shaped structure. In the securing state, the first portion may be embedded in the tissue and the medial portion may contact the article. A system for securing the article to the tissue may releasably engage the device while in the deployment state. A method for securing the article may include contacting the article with a tissue surface and releasing the device from the system so that the device, in the securing state, may anchor the article to the tissue.

CLAIM OF PRIORITY

This application is a divisional of U.S. application Ser. No.14/897,921, entitled “DEVICE, SYSTEM, AND METHOD TO SECURE AN ARTICLE TOA TISSUE,” filed Dec. 11, 2015, which is a U.S. national stage filingunder 35 U.S.C. § 371 of International Application No. PCT/US2014/044920entitled “DEVICE, SYSTEM, AND METHOD TO SECURE AN ARTICLE TO A TISSUE,”filed Jun. 30, 2014, which claims benefit of and priority to U.S.Provisional Patent Application No. 61/840,588, entitled “STAPLE ANDMETHOD TO DELIVER IT TO A TARGET SITE,” filed Jun. 28, 2013, thedisclosures of which are incorporated herein by reference in theirentirety.

BACKGROUND

Staples exist for a variety of applications in the medical field. Thereare staples that may fix soft tissues, boney tissues, and soft tissuesto boney tissues. Some staples may bring two or more tissues togetherwhile the staples are applied. Alternatively, staples may function tofix together some tissues that are brought together by other means, suchas by mechanical or chemical means (shape memory).

In some applications, staples may be designed to bring tissues togetherso the tissues may heal. In some alternative applications, one or morestaples may be used to hold or otherwise affix an instrument or otherstructure to one or more tissues. In some instances, however, aninstrument or structure may not be adapted to work with a staple due tosize or geometry.

Such medical staples may find use in a number of surgical ornon-surgical procedures including, without limitation, an open surgicalprocedure, an arthroscopic procedure, or in less invasive procedures.Additionally, staples may include additional features suited tospecialty applications including imaging applications, such asradiographic procedures.

SUMMARY

In an embodiment, a device for securing an article to a tissue may becomposed of a body, transitionable from a first deployment state to asecond securing state, having a first portion, a second portion, and amedial portion between the first portion and the second portion, inwhich the first portion has a first terminal end configured to piercethe tissue, and in which the second securing state comprises at least asection of the first portion of the body assuming a curved geometryembedded in the tissue and at least a section of the medial portion ofthe body contacting a surface of the article.

In an embodiment, a device for securing an article to a tissue may becomposed of a body, transitionable from a first deployment state to asecond securing state, having a first portion, a second portion, and amedial portion between the first portion and the second portion, inwhich the first portion has a first terminal end configured to piercethe tissue, and a tab standoff in mechanical communication with themedial portion of the body at a first end and a tab at a second end, inwhich the tab is displaced by a slot from the body. The first deploymentstate of the device may be a linearly extended state. In the secondsecuring state, the device has at least a section of the first portionof the body assuming a curved geometry embedded in the tissue and atleast a section of the second portion contacting a surface of thearticle.

In an embodiment, a device for securing an article to a tissue may becompose of a body, transitionable from a first deployment state to asecond securing state, having a first portion, a second portion, and amedial portion between the first portion and the second portion, inwhich the first portion has a first terminal end configured to piercethe tissue and the second portion has a second terminal end configuredto pierce the tissue. The first deployment state may be a U-shapedstate. In the second securing state, the device has at least a sectionof the first terminal end assuming a curved geometry embedded in thetissue, at least a section of the second terminal end assuming a curvedgeometry embedded in the tissue, and at least a section of the medialportion contacting a surface of the article.

In an embodiment, system for securing an article to a tissue byreleasably engaging at least one securing device may be composed of anexterior tube having a distal end, in which at least a portion of thedistal end of the exterior tube is configured to form a stablemechanical contact between the article and the tissue, and a push rod atleast partially disposed within the interior tube. The system may beconfigured to releasably engage at least one securing device having abody transitionable from a first deployment state to a second securingstate, and the push rod may be configured to effect a release of the atleast one securing device, thereby allowing the securing device body totransition from the first deployment state to the second securing state.

In an embodiment, a method of securing an article to a tissue, may becomposed of providing a system for securing the article to the tissue,the system composed of a housing having a distal end, in which at leasta portion of the distal end of the housing is configured to engage thearticle with a surface of the tissue, providing at least one securingdevice composed of a body, transitionable from a first deployment stateto a second securing state, having a first portion, a second portion,and a medial portion between the first portion and the second portion,in which the first portion has a first terminal end configured to piercethe tissue, and wherein the second securing state comprises at least asection of the first portion of the body assuming a curved geometryembedded in the tissue and at least a section of the medial portion ofthe body assuming a curved geometry around a surface of the article,releasably engaging the securing device in the first deployment statewithin the system for securing the article, engaging, by least a portionof the distal end of the housing, the article with the surface of thetissue, releasing the securing device from the distal end of thehousing, thereby allowing the body to assume the second securing stateand securing the article against the surface of the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a side view of a securing device having a linearlyextended deployment state according to an embodiment.

FIG. 1B depicts a side view of a securing state of a securing devicehaving a linearly extended deployment state according to an embodiment.

FIG. 1C depicts a side view of an article secured to a tissue surface bya securing device having a linearly extended deployment state accordingto an embodiment.

FIG. 2A depicts a side view of a securing device having a U-shapeddeployment state according to an embodiment.

FIG. 2B depicts a 3-D view of an article secured by a securing devicehaving a U-shaped deployment state according to an embodiment.

FIGS. 2C-2F depict 3-D views of exemplary securing states attainable bya securing device having a U-shaped deployment state according to anembodiment.

FIGS. 3A-3C depict use of a system to secure an article to a surface ofa tissue using a securing device having a linearly extended deploymentstate according to an embodiment.

FIGS. 4A-4D depict use of a system to secure an article to a surface ofa tissue using a securing device having a U-shaped deployment stateaccording to an embodiment.

FIGS. 5A-5D depict a manner in which an article may be secured to asurface of a tissue by the use of a securing device having a U-shapeddeployment state according to an embodiment.

FIG. 6 is a flow chart for a method of securing an article to a surfaceof a tissue using a securing device having a deployment state and asecuring state according to an embodiment.

DETAILED DESCRIPTION

In some applications, there may be a need to attach an article to atissue, and especially a need for the article to be in close proximityto (for example, in physical contact with) the tissue. In many surgicalprocedures, articles may be secured through the use of one or moresutures, staples, and clamps. Sutures may be used in a wide variety ofprocedures because sutures, comprising flexible material, may take onthe shape of the surface of the article being attached. However,suturing is a time-consuming process, and there may be variability inthe degree of stabilization of the article to the tissue surface due tothe innate variability of suture application. Additionally, the flexiblesuturing material may have a limited tensile strength that may not bestrong enough for some applications.

Staples and clips may require less time to apply. Staplers, used toapply the staples, may provide more consistent force for securing thearticle to the tissue. As a result, there is less variability in forceapplied to the article, especially if a number of staples are used. Suchstaples and clips are typically made of metal, which has a greatertensile strength than sutures. However, staples and clips, because theyare more rigid than sutures, may not readily conform to the surface ofthe article being secured. As a result, the article secured by thestaples or clips may shift because the clip/article interface is notexact.

Disclosed herein is a device for securing an article to a tissue inwhich the device combines useful features of both sutures and staples.Specifically, the securing device disclosed herein may adjust to thesurface geometry of the article being secured while being easily appliedfrom a stapler-type system. In some examples, the article may includeone or more cardiovascular implant articles. In some examples, thetissue may comprise a soft tissue such as one or more of a muscletissue, a tendon tissue, a ligament tissue, and a cardiovascular tissue.

In some applications, the device may place the article in closeproximity to the tissue. Alternatively, the device may be used to causethe article to physically contact the tissue. In some alternativeapplications, the securing device may be used to secure two portions oftissue together with or without securing a non-tissue article thereto.

Additionally, a system for deploying the device is disclosed herein. Insome embodiments, the system may be an arthroscopic delivery device ormay be part of an arthroscopic device. Such arthroscopic devices may beused, for example, during open surgical procedures or in minimallyinvasive surgical procedures. In some medical procedures, it may benecessary to visualize the attachment of the device to the tissue andarticle. Examples of visualization methods may include radiographicmethods and ultrasound methods. The device disclosed herein generallyhas a two dimensional design and function, thereby accommodating suchvisualization techniques.

The disclosed device can be used in a variety of procedures in which oneor more devices and/or one or more tissues may be involved. In oneexample, an article may be partially pre-attached to a tissue by analternative means, such as by gluing, and a more robust attachment isrequired. In another example, the article may be in physical proximityto the tissue but may lack any secure attachment. In yet anotherexample, the article may be completely attached to the tissue andadditional locking between the article and the tissue may be required.

In one non-limiting example, the article may include one or more suturesor polymers and the tissue may include one of the papillary muscles.Such a procedure may find use in repairing or replacing one or more ofthe chordae tendineae by providing an anchor for the suture or polymerin the muscle to which the replacement may be attached.

The disclosed device can also be used as a means to attach two articlestogether. In one non-limiting embodiment, the first article may be apreviously implanted article already fixed at a target site and thesecond article may be a new structure to be fixed to the first articleand/or the surrounding tissue. As a non-limiting example, the firstarticle may be a D-shaped or round annuloplasty ring that is implantedin a mitral valve annulus, and the second article may include aprosthetic valve designed to work in concert with the annuloplasty ring.

As disclosed herein, the securing device may take on a variety ofembodiments as depicted in FIGS. 1A-1C and 2A-2F. It may be understoodthat such figures and embodiments are only examples and are notlimiting. Common to all the possible embodiments of the securing deviceis the ability of the device to transition between a deployment stateand a securing state. The deployment state may comprise a geometryconsistent with a device adapted to deliver the securing device, and mayinclude, without limitation, a linearly extended geometry or a U-shapedgeometry. The securing state may comprise a geometry capable ofcontacting the article with a tissue or other article and securing thearticle thereto. In some non-limiting embodiments, the securing statemay include contacting a portion of the securing device with at least aportion of a surface of the article to be secured, and embedding atleast one terminal or end portion of the securing device in the tissue.The at least one terminal or end portion of the securing device, in thesecuring state, may include a curved or angled geometry within thetissue, thereby providing an anchor for the device. It may be understoodthat the device, in transitioning from the deployment state to thesecuring state may assume any appropriate intermediate geometryconsistent with the initial (deployment) and final (securing) states.

Such securing devices may derive their property of transitioning from afirst geometric state to a second geometric state from the material ormaterials from which they are made. In particular, the securing devicesdisclosed herein may comprise one or more materials having a high yieldstress and high level of recoverable plastic strain. As a result ofthese properties, the device may be deformed from its relaxed shape(comprising the securing state) into a second shape (the deploymentstate) under force, but will return to the original relaxed shape oncethe force is removed.

In some non-limiting examples, the body of the securing device mayinclude one or more of a metal, a polymer, and a plastic. Non-limitingexamples of such metals may include 316 stainless steel, a cobaltchromium alloy, and combinations and alloys thereof. In somenon-limiting examples, the body of the securing device may include oneor more of a biocompatible material and a bio-absorbable material. Insome non-limiting examples, the biocompatible material may includepolyether ether ketone, a polyetherimide, or similar material. In somenon-limiting examples, the body of the securing device may include oneor more of a superelastic material and a shape memory alloy. Anon-limiting example of such a shape memory alloy may include a nickeltitanium alloy.

In addition to the materials to provide appropriate material properties,the securing devices may also include materials specific for thesecuring device function or use. Thus, in some embodiments, at least aportion of the body of the securing device may include a material thatis visualizable by a radiological technique, an MRI technique, and anultrasound technique.

In general, there are no limitations to any one or more of the physicaldimensions of the securing device, as the dimensions of any one securingdevice may depend, at least in part, on the article to be secured, thetissue to which it may be secured, and the system used to deploy thesecuring device and secure the article. In one embodiment, the body ofthe securing device may have a length of about 10 mm to about 30 mm.Examples of the body length of the securing device may include a lengthof about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm,about 20 mm, about 22 mm, about 24 mm, about 26 mm, about 28 mm, about30 mm, and any value or range between any two of these values includingendpoints. In one non-limiting example, the body of the securing devicemay have a length of about 20 mm. In some securing devices, the body mayhave a cross-sectional diameter of about 0.2 mm to about 1 mm. Examplesof the body cross-sectional diameter of the securing device may includea diameter of about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm,about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, andany value or range between any two of these values including endpoints.In one non-limiting example, the body of the securing device may have across-sectional diameter of about 0.5 mm.

In some embodiments, at least a portion of the body of the securingdevice may have a circular cross-section. In some securing devices, thebody may have a circular cross-sectional diameter of about 0.2 mm toabout 1.5 mm. Examples of the circular cross-sectional diameter of thesecuring device may include a diameter of about 0.2 mm, about 0.3 mm,about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm,about 0.9 mm, about 1 mm, about 1.3 mm, about 1.5 mm, and any value orrange between any two of these values including endpoints. In onenon-limiting example, the body of the securing device may have acircular cross-sectional diameter of about of about 0.8 mm.

In some embodiments, at least a portion of the body of the securingdevice may have a square or rectangular cross section. In some securingdevices, the body may have a rectangular cross-section having a firstcross-sectional diameter of about 0.2 mm to about 1 mm and a secondcross-sectional diameter of about 0.2 mm to about 1 mm. Examples of thefirst cross-sectional diameter of the securing device may include adiameter of about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm,about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, andany value or range between any two of these values including endpoints.Examples of the second cross-sectional diameter of the securing devicemay include a diameter of about 0.2 mm, about 0.3 mm, about 0.4 mm,about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm,about 1 mm, and any value or range between any two of these valuesincluding endpoints. In one non-limiting example, a securing devicehaving a rectangular cross-section may have a first cross-sectionaldiameter of about 0.5 mm and a second cross-sectional diameter of about0.8 mm.

FIG. 1A depicts a side view of one embodiment of a securing devicehaving a linearly extended deployment state. FIG. 1B depicts a side viewof the same securing device as FIG. 1A in the securing state.

As depicted in FIG. 1A, the securing device in the deployment state 10 amay include a first portion 12 a, a second portion 14 a, and a medialportion 13 a between the first portion and the second portion. The firstportion 12 a, the second portion 14 a, and the medial portion 13 atogether may all form a linearly extended structure. The first portion12 a may have a first terminal end 18 a having a sharpened point forpenetrating the tissue. In some alternative embodiments, the firstterminal end 18 a may include one or more barbs, one or more serrations,one or more hooks, or any combination thereof. The second portion 14 amay have a second terminal end (not shown) which, in some embodiments,may be a blunt end. The securing device in the deployment state 10 a mayalso include a tab standoff 17 a that is connected to a tab 11 a on oneend and to the medial portion 13 a of the securing device on the otherend. The tab 11 a may be displaced from the medial portion 13 a by aslot 15 a.

In some non-limiting examples, the tab 11 a may have a length of about 2mm to about 7 mm. Examples of the length of the tab 11 a may include alength of about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, and any value or range between any two of these valuesincluding endpoints. In one non-limiting example, the tab 11 a may havea length of about 5 mm. In some non-limiting examples, the tab 11 a mayhave a width of about 0.2 mm to about 1 mm. Examples of the width of thetab 11 a may include a width of about 0.2 mm, about 0.3 mm, about 0.4mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9mm, about 1 mm, and any value or range between any two of these valuesincluding endpoints. In one non-limiting example, the tab 11 a may havea width of about 0.5 mm. In some non-limiting examples, the tab 11 a maybe displaced from the medial portion 13 a of the body of the securingdevice by a slot 15 a having by a distance of about 0.5 mm to about 3 mmfrom the medial portion. Examples of the distance of the tab 11 a fromthe medial portion 13 a of the body may include a distance of about 0.5mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, andany value or range between any two of these values including endpoints.In one non-limiting example, the tab 11 a may have distance from themedial portion 13 a of the body of about 1.5 mm.

The securing device in the deployment state 10 a may also include afriction protrusion 16 a in mechanical communication with the medialportion of the body 13 a and proximate to the tab 11 a. In someembodiments, the tab 11 a may have a first end in mechanicalcommunication with the tab standoff 17 a and have a second free endapproximately opposite the friction protrusion 16 a without makingphysical contact with it. In some alternative embodiments, the secondfree end of the tab 11 a may be in mechanical contact with the frictionprotrusion 16 a. The friction protrusion 16 a and the tab 11 a may helpsecure the securing device in the extended state 10 a to a systemconfigured to deploy it, as disclosed below.

In some non-limiting embodiments, the friction protrusion 16 a may havea height of about 0.2 mm to about 1 mm. Examples of the height of thefriction protrusion 16 a may include a height of about 0.2 mm, about 0.3mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8mm, about 0.9 mm, about 1 mm, and ranges between any two of these valuesincluding endpoints. In one non-limiting example, the frictionprotrusion 16 a may have a height of about 0.5 mm.

As depicted in FIG. 1B, the securing device in FIG. 1A may assume asecuring state 10 b including a first portion 12 b, a second portion 14b, and a medial portion 13 b between the first portion and the secondportion. In contrast to FIG. 1A, the first portion 12 b in FIG. 1B mayassume a curved geometry. The first terminal end 18 b of the firstportion 12 b may include a sharpened point that may help anchor thesecuring device in the securing state 10 b to the tissue. In somealternative embodiments, the first terminal end 18 b may include one ormore barbs, one or more serrations, one or more hooks, or anycombination thereof. Also in contrast to FIG. 1A, the second portion 14b in FIG. 1B may assume a curved geometry. The securing device in thesecuring state 10 b may also include a tab standoff 17 b that isconnected to a tab 11 b on one end and to the medial portion 13 b of thesecuring device on the other end. The tab 11 b may be displaced from themedial portion 13 b by a slot 15 b.

FIG. 1C depicts a manner in which an article may be secured to thesurface of a tissue by the securing device depicted in FIGS. 1A and 1B.As illustrated in FIG. 1C, the article 2 may be held against the surfaceof a tissue 3 by means of the securing device in the securing state 10b. The first portion 12 b of the device may assume a curved geometrywithin the tissue 3, thereby forming a tissue anchor for the device. Thesecond portion 14 b of the device may contact at least a portion of asurface of the article 2, thereby securing the article against thesurface of the tissue 3. The medial portion of the device may also be incontact with at least a portion of the surface of the article 2. In somenon-limiting embodiments, the second portion 14 b may form a curvedgeometry around the surface of the article 2.

FIG. 2A depicts a side view of another embodiment of a securing devicehaving a U-shaped deployment state. FIG. 2B depicts a side view of thesame securing device as FIG. 2A in the securing state.

As depicted in FIG. 2A, the securing device in the deployment state 20 amay include a first portion 22 a, a second portion 24 a, and a medialportion 23 a between the first portion and the second portion. Incontrast to the securing device depicted in FIG. 1A, the first portion22 a and the second portion 24 a in the deployment state 20 a do notform a linearly extended structure, but may be effectively parallel toeach other. If the medial portion 23 a is curved, the deployment state20 a may form a U-shaped structure. The first portion 22 a may have afirst terminal end 28 a having a sharpened point for penetrating thetissue. In some alternative embodiments, the first terminal end 28 a mayinclude one or more barbs, one or more serrations, one or more hooks, orany combination thereof. The second portion 24 a may have a secondterminal end 29 a which may have a sharpened point for penetrating thetissue. In some alternative embodiments, the second terminal end 29 amay include one or more barbs, one or more serrations, one or morehooks, or any combination thereof. The securing device in the deploymentstate 20 a may also include additional features 21 a connected to themedial portion 23 a of the securing device. The additional features 21 amay be used to secure the device in the deployment state 20 a within asystem to secure an article to a surface of a tissue through the use ofone or more securing devices. The additional features 21 a may include athickened section of the medial portion 23 a, a broadened section of themedial portion, a flanged section of the medial portion, a perforatedsection of the medial portion, a hooked section of the medial portion(as depicted, for example, in FIG. 2E), or any combination thereof.

As depicted in FIG. 2B, the securing device in FIG. 2A may assume asecuring state 20 b including a first portion 22 b, a second portion 24b, and a medial portion 23 b between the first portion and the secondportion. In contrast to FIG. 2A, the first portion 22 b in FIG. 2B mayassume a curved geometry within the tissue. The first terminal end 28 bof the first portion 22 b may include a sharpened point that may helpanchor the securing device in the securing state 20 b to the tissue. Insome alternative embodiments, the first terminal end 28 b may includeone or more barbs, one or more serrations, one or more hooks, or anycombination thereof. Also in contrast to FIG. 2A, the second portion 24b in FIG. 2B may assume a curved geometry while embedded in the tissue.The second terminal end 29 b of the second portion 24 b may include asharpened point that may help anchor the securing device in the securingstate 20 b to the tissue. In some alternative embodiments, the secondterminal end 29 b may include one or more barbs, one or more serrations,one or more hooks, or any combination thereof. As depicted in FIG. 2B,the article 2 to be secured to the tissue may be contacted by a sectionof the first portion 22 b, a section of the medial portion 23 b, and asection of the second portion 24 b. The additional features 21 b mayalso be configured to assist with stabilizing the article 2 within thesecuring device in the securing state 20 b.

It may be appreciated that securing devices having parallel first andsecond portions in the deployment state may assume any of a number ofdifferent geometries in the securing state. For example, as depicted inFIG. 2B, the securing state may include the first and second portions orthe first and second terminal ends forming a scissor-like geometrywithin the tissue, thereby holding the article between them. As depictedin FIG. 2C, the first and second portions or the first and secondterminal ends may form a pair of opposing fish-hooks in the tissue andbelow the article. As depicted in FIG. 2D, the first and second portionsor the first and second terminal ends may form a pair of opposingfish-hooks in the tissue that point away from the article. As depictedin FIG. 2E, the first and second portions or the first and secondterminal ends may form a pair of opposing barbs in the tissue that pointaway from the article. As depicted in FIG. 2F, the first and secondportions or the first and second terminal ends may form aclothes-pin-type arrangement within the tissue pointing towards thearticle. It may be understood that the specific geometric arrangementsof the first portion, first terminal end, second portion, and secondterminal end in the securing state as depicted in FIGS. 2B-2F are merelyrepresentative examples, and do not limit the possible configurationsachievable by the securing device.

FIGS. 3A-3C depict one type of system configured to deploy a securingdevice and secure an article therewith to a surface of a tissue. Thesystem may be used with a securing device having a linearly extendeddeployment state.

The system may include an exterior tube 31 that may house the remainingcomponents. In one embodiment, the exterior tube 31 may include, at adistal end, a portion configured to form a mechanically stable contactbetween the article 2 and the surface of the tissue 3. In onenon-limiting example, the portion of the exterior tube 31 may comprise apawl 32. The pawl 32 may have a surface geometry complementary to thegeometry of at least a portion of an external surface of the article 2.The exterior tube 31 may be composed of one or more of a metal and aplastic. In some embodiments, the exterior tube 31 may be composed ofone or more of a stainless steel, a nickel titanium alloy, and a cobaltchrome alloy. In some embodiments, the exterior tube 31 may be composedof one or more of a polyether ether ketone, a polyether block amide, apolytetrafluoroethylene, a fluorinated ethylene propylene, and anextended polytetrafluoroethylene.

In general, there are no limitations to any one or more of the physicaldimensions of the system, as the dimensions of the system may depend, atleast in part, on the article to be secured, the tissue to which it maybe secured, and the securing device. In some non-limiting embodiments,the exterior tube 31 may have a diameter of about 3 mm to about 8 mm.Examples of the diameter of the exterior tube 31 may include a diameterof about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8mm, and any value or range between any two of these values includingendpoints. In one non-limiting example, the exterior tube 31 may have adiameter of about 5 mm.

The system may also include a medial tube 34 disposed at least partiallywithin the exterior tube 31, an interior tube 36 at least partiallydisposed within the medial tube, and a push rod 38 at least partiallydisposed within the interior tube.

The medial tube 34 may be composed of one or more of a metal and aplastic. In some non-limiting examples, the medial tube 34 may becomposed of one or more of a stainless steel, a nickel titanium alloy,and a cobalt chrome alloy. In some other non-limiting examples, themedial tube 34 may be composed of or more of a polyether ether ketone, apolyether block amide, a polytetrafluoroethylene, a fluorinated ethylenepropylene, and an extended polytetrafluoroethylene.

The interior tube 36 may be composed of one or more of a metal and aplastic. In some non-limiting examples, the medial tube 36 may becomposed of one or more of a stainless steel, a nickel titanium alloy,and a cobalt chrome alloy. In some other non-limiting examples, themedial tube 36 may be composed of or more of a polyether ether ketone, apolyether block amide, a polytetrafluoroethylene, a fluorinated ethylenepropylene, and an extended polytetrafluoroethylene.

The push rod 38 may be composed of a metal. In some non-limitingexamples, the push rod 38 may be composed of one or more of a stainlesssteel, a nickel titanium alloy, and a cobalt chrome alloy.

As depicted in FIG. 3A, the interior tube 36 may have an exteriorsurface, the medial tube 34 may have an interior surface, and theinterior tube and the medial tube may be configured to releasably engagethe at least one securing device 10 in the first deployment statetherebetween. The medial tube 34 may have a distal end configured toengage a slot between a tab and the body of the securing device 10.Additionally, the push rod 38 may have a distal end configured to engagean end of the tab of the securing device 10. In one non-limitingembodiment, the interior tube 36 may further have at least one detentconfigured to form a mechanical contact with at least one frictionprotrusion of the at least one securing device 10.

The securing device and system depicted in FIGS. 3A-3C may operate inthe following manner. As illustrated in FIG. 3A, a securing device 10having a linearly extended deployment state may be engaged by the systemin a space between the medial tube 34 and the interior tube 36. A distalend of the interior tube 36 may engage a slot of the securing device 10and the exterior end of the push rod 38 may engage a tip end of the tabof the securing device. The article 2 may be stabilized against thesurface of the tissue 3 by the pawl 32. As illustrated in FIG. 3B, thepush rod 38 and interior tube 36 may be moved in a distal direction.Because of the engagement of the slot with the interior tube 36 and thetab with the push rod 38, the securing device 10 may be displaced in thedistal direction, thereby forcing the first portion of the securingdevice to penetrate the tissue 3 and releasing the securing device 10from the system. The first portion of the securing device 10 maycontinue penetrating the tissue 3 until the tab standoff 37 contacts thesurface of the tissue. The first portion of the securing device 10, freeof the system, may then assume a curved geometry within the tissue 3,constituting a portion of the securing state of the device. Asillustrated in FIG. 3C, once the first portion of the securing device 10has assumed a curved geometry within the tissue 3, thereby anchoring atleast a portion of the securing device, the medial tube 34 and theinterior tube 36 may be moved in the proximal direction. In this manner,the second portion of the securing device 10 may be freed from thesystem and allowed to assume the curved geometry of the securing state.In some embodiments, the securing state may include the second portionof the securing device 10 forming a curved contact with at least aportion of the surface of the article 2.

An alternative embodiment of a system for securing an article to atissue is depicted in FIGS. 4A-4D. In the system depicted in FIGS.4A-4D, the securing device may be one having a U-shaped deploymentstate. In FIG. 4A, the one or more securing devices 10 may initially beengaged within the delivery system 44. The delivery system 44 mayinclude a distal end having a surface geometry complementary to thegeometry of at least a portion of an external surface of the article tobe secured. As depicted in FIG. 4B, the delivery system 44 may bebrought in proximal contact to the article 2 to be secured. The article2 may be contacted with the distal end of the system 44 at the distalend having the complementary geometry to the article, as depicted inFIG. 4C. FIG. 4D illustrates that a securing device 10 may be releasedfrom the system 44 to contact the article 2. The securing device 10 maybe released from the system 44 according to any of a number of meansincluding the use of a push rod (not shown).

FIGS. 5A-5D depict the interaction of a securing device 10 with anarticle 2 and a tissue 3 to which the article may be secured. Asillustrated in FIGS. 5A-5D, the securing device 10 may be one having aU-shaped deployment state. FIG. 5A illustrates the article 2 proximateto the surface of the tissue 3. The securing device 10 may be in adeployment state, as indicated by the U-shape of the securing device. Inthe deployment state, such a securing device 10 may have a first portion22 a, and a second portion 24 a in a roughly parallel orientation. Amedial portion 23 a is disposed between the first portion 22 a and thesecond portion 24 a. Together, the first portion 22 a, the secondportion 24 a, and the medial portion 23 a may surround the article 2. Asdepicted in FIG. 5B, the first terminal end from the first portion 22 a,and the second terminal end of the second portion 24 a may contact thesurface of the tissue 3. As illustrated in FIG. 5B, the securing device10 may still be in the deployment state, as indicated by the indexletter ‘a’ associated with each of the figure component labels. Thesecuring device 10, as illustrated in FIG. 5C, may be advanced in adistal direction, causing the first section 22 c and the second section24 c to begin their respective transitions from the deployment state tothe securing state (as indicated by the letter ‘c’ in the componentlabels.) The medial portion 23 c may also transition between adeployment state to a securing state. In FIG. 5D, the securing device 10has transitioned to the securing state, as indicated by the index letter‘b’ associated with each of the figure component labels. In the securingstate, the first portion 22 b and second portion 24 b may assume theirrespective curved geometries within the tissue 3. The article 2 may thusbe anchored to the surface of the tissue 3 by means of the first portion22 b, second portion 24 b, and medial portion 23 b of the securingdevice 10.

FIG. 6 is a flow chart of a method for securing an article to a tissue.The method may include providing 610 a system for securing the articleto the tissue. In some embodiments, the system may include a housinghaving a distal end, in which at least a portion of the distal end ofthe housing may be configured to engage the article with a surface ofthe tissue. In some non-limiting examples, the system for securing thearticle to the tissue may further include a medial tube at leastpartially disposed within the system housing, an interior tube at leastpartially disposed within the medial tube, and a push rod at leastpartially disposed within the interior tube.

The method may also include providing 620 at least one securing device.In some embodiments, the at least one securing device may include abody, transitionable from a first deployment state to a second securingstate, having a first portion, a second portion, and a medial portionbetween the first portion and the second portion. The first portion ofthe securing device may further have a first terminal end configured topierce the tissue. Additionally, the second securing state of thesecuring device may include at least a section of the first portion ofthe body assuming a curved geometry embedded in the tissue and at leasta section of the medial portion of the body contacting a surface of thearticle.

In one non-limiting example, the first deployment state of the securingdevice may take the form of a U-shaped state, and the second securingstate may include at least a section of a first terminal end of thefirst portion assuming a curved geometry embedded in the tissue, atleast a section of a second terminal end of the second portion assuminga curved geometry embedded in the tissue, and at least a section of themedial portion contacting a surface of the article

In another non-limiting example, the first deployment state of thesecuring device may take the form of a linearly extended state, and thesecond securing state may further include at least a section of thefirst portion of the body assuming a curved geometry embedded in thetissue and at least a section of the second portion contacting a surfaceof the article. In some additional non-limiting examples, the securingdevice may further include a tab standoff in mechanical communicationwith the medial portion of the body at a first standoff end and a tab ata second standoff end, in which the tab may be displaced by a slot fromthe body.

The securing device, while in a deployment state, may be releasablyengaged 630 with the deployment system. In some embodiments, the atleast one securing device may include a tab standoff in mechanicalcommunication with the medial portion of the body of the securing deviceat a first standoff end and a tab at a second standoff end, therebydisplacing the tab from the body by a slot. For such a securing device,releasably engaging 630 the device within the system for securing thearticle may further include releasably engaging the slot of the devicewith a portion of the deployment system. In one example, such adeployment system may include an interior tube having a distal end thatmay engage 630 the slot of the securing device.

In some embodiments, the at least one securing device may also include afriction protrusion in mechanical communication with the body andproximate to a tab. For such a securing device, releasably engaging thedevice within the system for securing the article may further includereleasably engaging the friction protrusion with a detent on an exteriorsurface of an interior tube of the deployment system.

The deployment system may be used to engage 640 the article with thesurface of the tissue. In some embodiments, the article may be engaged640 with the surface of the tissue using at least a portion of a distalend of the housing.

The securing device may be released 650 from the deployment system,thereby allowing the body of the securing device to assume the secondsecuring state and securing the article against the surface of thetissue. In some non-limiting embodiments, releasing 650 the securingdevice from the distal end of the housing may include contacting the tabof the securing device with a distal end of a deployment system pushrod, extending the push rod in a distal direction, and extending amedial tube of the deployment system in a proximal direction.

In the above detailed description, reference is made to the accompanyingdrawings, which form a part hereof. In the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, drawings, and claims are not meant to be limiting. Otherembodiments may be used, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in theFigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which areexplicitly contemplated herein.

The present disclosure is not to be limited in terms of the particularembodiments described in this application, which are intended asillustrations of various aspects. Many modifications and variations canbe made without departing from its spirit and scope, as will be apparentto those skilled in the art. Functionally equivalent methods andapparatuses within the scope of the disclosure, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions. Such modifications and variations are intendedto fall within the scope of the appended claims. The present disclosureis to be limited only by the terms of the appended claims, along withthe full scope of equivalents to which such claims are entitled. It isto be understood that this disclosure is not limited to particularmethods, reagents, compounds, compositions or biological systems, whichcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular embodimentsonly, and is not intended to be limiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” et cetera). While various compositions, methods, anddevices are described in terms of “comprising” various components orsteps (interpreted as meaning “including, but not limited to”), thecompositions, methods, and devices can also “consist essentially of” or“consist of” the various components and steps, and such terminologyshould be interpreted as defining essentially closed-member groups. Itwill be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (for example, “a” and/or “an” should be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould be interpreted to mean at least the recited number (for example,the bare recitation of “two recitations,” without other modifiers, meansat least two recitations, or two or more recitations). Furthermore, inthose instances where a convention analogous to “at least one of A, B,and C, et cetera” is used, in general such a construction is intended inthe sense one having skill in the art would understand the convention(for example, “a system having at least one of A, B, and C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, et cetera). In those instances where a conventionanalogous to “at least one of A, B, or C, et cetera” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (for example, “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, et cetera). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, et cetera As a non-limiting example, each range discussed hereincan be readily broken down into a lower third, middle third and upperthird, et cetera As will also be understood by one skilled in the artall language such as “up to,” “at least,” and the like include thenumber recited and refer to ranges which can be subsequently broken downinto subranges as discussed above. Finally, as will be understood by oneskilled in the art, a range includes each individual member. Thus, forexample, a group having 1-3 cells refers to groups having 1, 2, or 3cells. Similarly, a group having 1-5 cells refers to groups having 1, 2,3, 4, or 5 cells, and so forth.

Various of the above-disclosed and other features and functions, oralternatives thereof, may be combined into many other different systemsor applications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, each of which is alsointended to be encompassed by the disclosed embodiments.

What is claimed is:
 1. A device for securing an article to a tissue, thedevice comprising: a body, transitionable from a first deployment stateto a second securing state, having a first portion, a second portion,and a medial portion between the first portion and the second portion,wherein the first portion has a first terminal end configured to piercethe tissue, and wherein the second securing state comprises at least asection of the first portion of the body assuming a curved geometryembedded in the tissue and at least a section of the medial portion ofthe body contacting a surface of the article.
 2. The device of claim 1,wherein the article comprises a cardiovascular implant article.
 3. Thedevice of claim 1, wherein the tissue comprises a soft tissue.
 4. Thedevice of claim 1, wherein the tissue comprises one or more of a muscletissue, a tendon tissue, a ligament tissue, and a cardiovascular tissue.5. The device of claim 1, wherein the body comprises one or more of ametal, a polymer, and a plastic.
 6. The device of claim 1, wherein thebody comprises one or more of a biocompatible material.
 7. The device ofclaim 1, wherein the body comprises one or more of a superelasticmaterial and a shape memory alloy.
 8. The device of claim 1, wherein atleast a portion of the body comprises a material that is visualizable byone or more of a radiological technique, an MRI technique, and anultrasound technique.
 9. The device of claim 1, wherein the body has alength of about 10 mm to about 30 mm.
 10. The device of claim 1, whereinthe body has a length of about 20 mm.
 11. The device of claim 1, whereinthe body has a cross-sectional diameter of about 0.2 mm to about 1 mm.12. The device of claim 1, wherein the body has a cross-sectionaldiameter of about 0.5 mm.
 13. The device of claim 1, wherein at least aportion of the body has a circular cross-section.
 14. The device ofclaim 13, wherein the circular cross-section has a diameter of about 0.2mm to about 1.5 mm.
 15. The device of claim 13, wherein the circularcross-section has a diameter of about 0.8 mm.
 16. The device of claim 1,wherein at least a portion of the body has a rectangular cross section.17. The device of claim 16, wherein the rectangular cross-section has afirst cross-sectional diameter of about 0.2 mm to about 1 mm and asecond cross-sectional diameter of about 0.2 mm to about 1 mm.
 18. Thedevice of claim 16, wherein the rectangular cross-section has a firstcross-sectional diameter of about 0.5 mm and a second cross-sectionaldiameter of about 0.8 mm.
 19. The device of claim 1, wherein the firstterminal end comprises one or more barbs, one or more serrations, one ormore hooks, or any combination thereof.
 20. The device of claim 1,wherein the first deployment state comprises a linearly extended state.21. The device of claim 20, wherein the second securing state furthercomprises at least a section of the second portion assuming a curvedgeometry around the surface of the article.
 22. The device of claim 20,wherein the second portion has a second terminal end comprising a bluntend.
 23. The device of claim 20, further comprising a tab standoff inmechanical communication with the medial portion of the body at a firstend and a tab at a second end, wherein the tab is displaced by a slotfrom the body.
 24. The device of claim 23, wherein the tab has a lengthof about 2 mm to about 7 mm.
 25. The device of claim 23, wherein the tabhas a length of about 5 mm.
 26. The device of claim 23, wherein the tabhas a width of about 0.2 mm to about 1 mm.
 27. The device of claim 23,wherein the tab has a width of about 0.5 mm.
 28. The device of claim 23,wherein the tab is displaced from the body by a distance of about 0.5 mmto about 3 mm.
 29. The device of claim 23, wherein the tab is displacedfrom the body by a distance of about 1.5 mm.
 30. The device of claim 23,further comprising a friction protrusion in mechanical communicationwith the medial portion of the body and proximate to the tab.
 31. Thedevice of claim 30, wherein the friction protrusion has a height ofabout 0.2 mm to about 1 mm.
 32. The device of claim 30, wherein thefriction protrusion has a height of about 0.5 mm.
 33. The device ofclaim 30, wherein the tab has a first end in mechanical communicationwith the tab standoff and a second free end opposite the frictionprotrusion.
 34. The device of claim 33, wherein the second free end ofthe tab is in mechanical contact with the friction protrusion.
 35. Thedevice of claim 1, wherein the first deployment state comprises thefirst portion of the body being about parallel to the second portion ofthe body.
 36. The device of claim 35, wherein the first deployment statecomprises the body assuming a U-shape.
 37. The device of claim 35,wherein the second portion has a second terminal end configured topierce the tissue.
 38. The device of claim 37, wherein the secondterminal end comprises one or more barbs, one or more serrations, one ormore hooks, or any combination thereof.
 39. The device of claim 37,wherein the second securing state further comprises at least a sectionof the second portion of the body assuming a curved geometry embedded inthe tissue.